FDA Clears Journey Medical's Emrosi for Rosacea Treatment

The US FDA has given approval for Journey Medical's Emrosi, a brand name for their 40mg minocycline hydrochloride extended-release capsules, for treating the skin condition rosacea. Created with the help of Dr Reddy's Laboratories, Emrosi (formerly DFD-29) has been backed by favorable results obtained from two 16-week Phase III clinical studies. In July 2023, the findings indicated that DFD-29 met all primary and secondary goals, proving its safety and effectiveness when compared to Oracea, owned by Galderma Laboratories.

Journey Medical now intends “to establish Emrosi as a new standard of care in the treatment of rosacea.” This is according to CEO Claude Maraoui, who believes the drug “has the potential to become the best-in-class oral medication to treat the condition”.

Journey has stated that they are currently finishing the production of Emrosi for the US market. It foresees that adult rosacea patients will have access to the initial supply by the first half of 2025.

The launch will mark a change in the treatment landscape. GlobalData’s 2022 ‘Rosacea Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape‘ report stated that Galderma was “the most prominent player in the rosacea space, offering a comprehensive portfolio of solutions”. However, it also warned that with “no presence in the late-stage pipeline and with its existing marketed products widely genericised, the company may lose its position in the rosacea market”.